Stress, PhysiologicalPECRMNCT05304000
Psychophysiological Effects of Controlled Respiration and Mindfulness
A study testing Mindfulness Meditation, Cyclic Sighing Breathing and Box Breathing in people with Stress, Physiological and Stress, Emotional, run by Stanford University at 2 sites in United States.
Trial summary
The investigators aim to understand the effectiveness of 3 types of breathwork exercises and a mindfulness meditation control on improving psychological and physiological measures of wellbeing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Physiological, Stress, Emotional, Insomnia
- What is being tested?
- Mindfulness Meditation, Cyclic Sighing Breathing and Box Breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jun 2020to 17 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Not pregnant
- Able to follow basic instruction for prescreen and scheduling
- Compliant with investigator instructions during the consent process and participation in the study
Who cannot join
- Age <18
- Pregnant
- Non-English speaking
- Anyone with personality disorders or psychosis such as schizoaffective disorder
- Demonstrates evidence of severe psychiatric disorder in prescreen or email contact (as judged by Dr. Spiegel)
- Glaucoma
Show all 13Show fewer
- History of seizures
- Suicidal
- Heart disease (based on PI's clinical judgement, dependent on the severity of the symptoms)
- Current untreated psychosis, or bipolar disorder, or substance/alcohol abuse/dependence (based on PI's clinical judgement, dependent on the severity of the symptoms)
- Any Medical condition that could be exasperated by study participation (based on PI's clinical judgement)
- Non USA mailing address to receive the WHOOP strap
- Vision or hearing impairment severe enough to interfere with study participation,
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Neurobiology and Ophthalmology
Palo Alto, California, 94304
Dept. of Psychiatry, Stanford University
Stanford, California, 94305
About this study
Official title: Psychophysiological Effects of Controlled Respiration: Noninvasive Relaxation Techniques
The investigators aim to understand the effectiveness of 3 types of breathwork exercises and a mindfulness meditation control on improving psychological and physiological measures of wellbeing. The interventions will be delivered remotely and effects are monitored through daily surveys and physiological monitoring with WHOOP wristband through a 28-day period. The information gained will help develop the most effective remote interventions for lowering stress and improving wellbeing. The study will be run on a healthy general population. The three breathing conditions were 1) Cyclic Sighing, which emphasizes relatively prolonged exhalations, 2) Box Breathing, which is equal duration of inhalations, breath retentions, exhalations and breath retentions, and 3) Cyclic Hyperventilation with Retention, with longer, more intense inhalations and shorter, passive exhalations. Mindfulness Meditation practice involved passive attention to breath.
Read the detailed description
PRIMARY OBJECTIVES:
- Examine psychological and physiological effects of breathwork in general in comparison to mindfulness meditation.
SECONDARY OBJECTIVES:
- Examine the effectiveness of specific breathwork protocols in improving mood and physiological wellness metrics in comparison to mindfulness meditation.
OUTLINE:
Of 140 potential participants who consented, 134 were randomized to the four interventions (3 were lost to follow-up and 3 were excluded due to lack of WHOOP straps at this stage). Out of the 134 that were randomized, 108 were enrolled. The primary reasons for attrition at this stage were due to pandemic-related reasons or loss of contact with the participants.
From the 108 subjects enrolled, 24 were randomized into the Mindfulness Meditation control condition and 84 were randomized to the treatment conditions (30 Cyclic Sighing, 21 Box Breathing, 33 Cyclic Hyperventilation with Retention). The initial randomization consisted of a permuted block randomization design with a block size of eight.
Both prior to and after the 28-day intervention, participants completed two brief questionnaires to assess the impact of the intervention on the daytime sequelae of sleep and anxiety: PROMIS Sleep Related Impairment - Short Form 8a, and the State-Trait Anxiety Questionnaire. Participants also completed a debriefing questionnaire at the end of the study. During the 28-day intervention period, participants did their assigned 5-minute exercise and completed two questionnaires before and after, the State Anxiety Inventory and the Positive and Negative Affect Schedule (PANAS). Participants received invitations to instructional videos (pre-recorded by Andrew D. Huberman) on the breathing exercises 3-5 days prior to the start of the study as well as daily text messages that reminded them to complete their exercises and pre-and-post-practice assessments. They were asked to complete the exercises only once a day.
- Conditions
- Stress, Physiological, Stress, Emotional, Insomnia
- Being tested
- Mindfulness Meditation, Cyclic Sighing Breathing, Box Breathing, Cyclic Hyperventilation with Retention
- Keywords
- stress, breathwork, mindfulness meditation, mood, anxiety, wearable, physiology
- Medical subject headings
- Stress, Psychological, Sleep Initiation and Maintenance Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness MeditationBehavioural
Participants are informed they should sit down in a chair or, if they preferred, to lie down, and then to set a timer for 5 minutes. Then they are told to close their eyes and to start breathing while focusing their mental attention on their forehead region between their two eyes. They are told that if their focus drifted from that location to re-recenter their attention by focusing back first on their breath and then on the forehead region between their eyes. They are told that as thoughts arise, to recognize that as normal, refocus their attention back to their forehead region and to continue the practice until time has elapsed.
Cyclic Sighing BreathingBehavioural
Participants are informed they should sit down in a chair or, if they prefer, to lie down, and to set a timer for 5 minutes. Then they are told to inhale slowly, and that once their lungs are expanded, to inhale again once more to maximally fill their lungs -- even if the second inhale was shorter in duration and smaller in volume than the first, and then to slowly and fully exhale all their breath. They are told to repeat this pattern of breathing for 5 minutes. They are also informed that ideally, both inhales would be performed via their nose and the exhale would be performed via their mouth, but that if they preferred, they are welcome to do the breathing entirely through their nose. They are also informed that it is normal for the second inhale to be briefer than the first.
Box BreathingBehavioural
Participants are informed they should sit down in a chair or lie down, and to get a timer. Then they are told to take the "CO2 tolerance test" as follows: Take 4 breaths through the nose. Then take a maximally deep breath and once your lungs are full, exhale as slowly as possible through your nose or mouth. Time how long it takes to empty your lungs; this will be your C02 discard duration. Use your discard duration to determine how long your inhales, exhales, and breath holds should be (CO2 discard time) by using this table: <20 sec = 3 - 4 sec, 25 - 45 sec = 5 - 6 sec, 50 - 75+ sec = 8 -10 sec. They are then told to inhale, hold, exhale, hold (for the duration determined by the C02 discard table) and to repeat this pattern for the entire 5 minutes. If at any point they had to strain to reach these times, they should simply reduce the duration of inhales, exhales, and breath holds. We ask participants to perform all breathing through their nose, if possible.
Cyclic Hyperventilation with RetentionBehavioural
Participants are informed they should sit down in a chair or, if they prefer, to lie down, and to set a timer for 5 min. Then they are told to inhale deeply (ideally through their nose but if that is not possible, to inhale through their mouth) and then exhale by passively letting the air "fall out from the mouth". We inform them that for sake of this protocol, that pattern of a deep inhale through the nose and passively letting the air "fall out from the mouth" = 1 breath.
Then they are instructed to perform 30 breaths (in and out) in this manner, and after those 30 breaths, to exhale all their air via their mouth and to calmly wait with lungs empty for 15 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Meditation | Active comparator | 5 minutes a day of mindfulness meditation practice for 28 days (passive attention to breath) delivered remotely through a video link. Receives: Behavioral: Mindfulness Meditation |
| Cyclic Sighing Breathing | Experimental | 5 minutes a day of active breathwork practice for 28 days delivered remotely through a video link. The protocol consists of slow inhales until lungs felt full then one more inhale to maximally fill the lungs, followed up a slow exhale. Repeat this cycle for 5 minutes. Receives: Behavioral: Cyclic Sighing Breathing |
| Box Breathing | Experimental | 5 minutes a day of active breathwork practice for 28 days delivered remotely through a video link. The protocol consists of equal duration of inhale, hold, exhale, hold cycles. The duration of the cycle is determined by the participant's comfort level with holding. (e.g. 4 sec inhale, 4 sec hold, 4 sec exhale, 4 sec hold). Repeat this cycle for 5 minutes. Receives: Behavioral: Box Breathing |
| Cyclic Hyperventilation with Retention | Experimental | 5 minutes a day of active breathwork practice for 28 days delivered remotely through a video link. The protocol consists of 30 breaths (inhale deeply through the nose and exhale passively through the mouth) and after those 30 breaths, to exhale all their air via their mouth and to calmly wait with lungs empty for 15 seconds. Repeat this cycle for 5 minutes. Receives: Behavioral: Cyclic Hyperventilation with Retention |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety
STAI State Trait Anxiety
Measured: Daily from Day 0 to 29
Trait Anxiety
STAI State Trait Anxiety
Measured: Day 0 and Day 29 (Baseline and Endpoint)
Positive Affect
PANAS Positive Affect
Measured: Daily from Day 1 to 28
Negative Affect
PANAS Negative Affect
Measured: Daily from Day 1 to 28
Daytime Sleep Related Disturbance
PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Sleep Related Impairment Short Form 8a
Measured: Day 0 and Day 29 (Baseline and Endpoint)
Resting Heart Rate
Daily obtained from WHOOP wrist band
Measured: Daily from Day 1 to 28
Heart Rate Variability
Daily obtained from WHOOP wrist band
Measured: Daily from Day 1 to 28
Respiratory Rate
Daily obtained from WHOOP wrist band
Measured: Daily from Day 1 to 28
Sleep Duration
Daily obtained from WHOOP wrist band
Measured: Daily from Day 1 to 28
Change in number of hours of sleep
Daily obtained from WHOOP wrist band as Hours of Sleep. Changes in the hours of sleep will be assessed with more hours indicating better sleep.
Measured: Daily from Day 1 to 28
Change in the ratio of number of hours of sleep to hours in bed
Obtained daily from WHOOP wrist band as sleep efficiency. Changes in the Whoop Sleep Efficiency score will be assessed with higher score (ratio) indicating higher sleep efficiency.
Measured: Daily from Day 1 to 28
Secondary outcomes (1)
Adherence to Protocol
Number of days subjects did their exercises out of the 28 days assigned
Measured: Daily from Day 1 to 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start2 Jun 2020
- Primary completion17 Sep 2020
- Study completion17 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PhysiologicalStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Spiegel, Stanford University
- Investigators
- David Spiegel, M.D., Principal investigator, Professor of Psychiatry, Stanford UniversityAndrew Huberman, Ph.D., Principal investigator, Stanford UniversityManuela Kogon, M.D., Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304000
- Sponsor's protocol ID
- 41398
- Acronym
- PECRM
- Status last verified
- May 2022
- First submitted
- 11 Mar 2022
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychophysiological Effects of Controlled Respiration: Noninvasive Relaxation Techniques
- ClinicalTrials.gov ID
- NCT05304000
- Acronym / sponsor ID
- PECRM / 41398
- Conditions
- Stress, Physiological, Stress, Emotional, Insomnia
- Keywords
- stress, breathwork, mindfulness meditation, mood, anxiety, wearable, physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 17 Sep 2020 (actual)
- Study completion
- 17 Sep 2020 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to understand the effectiveness of 3 types of breathwork exercises and a mindfulness meditation control on improving psychological and physiological measures of wellbeing. The interventions will be delivered remotely and effects are monitored through daily surveys and physiological monitoring with WHOOP wristband through a 28-day period. The information gained will help develop the most effective remote interventions for lowering stress and improving wellbeing. The study will be run on a healthy general population. The three breathing conditions were 1) Cyclic Sighing, which emphasizes relatively prolonged exhalations, 2) Box Breathing, which is equal duration of inhalations, breath retentions, exhalations and breath retentions, and 3) Cyclic Hyperventilation with Retention, with longer, more intense inhalations and shorter, passive exhalations. Mindfulness Meditation practice involved passive attention to breath.
Detailed description
PRIMARY OBJECTIVES:
- Examine psychological and physiological effects of breathwork in general in comparison to mindfulness meditation.
SECONDARY OBJECTIVES:
- Examine the effectiveness of specific breathwork protocols in improving mood and physiological wellness metrics in comparison to mindfulness meditation.
OUTLINE:
Of 140 potential participants who consented, 134 were randomized to the four interventions (3 were lost to follow-up and 3 were excluded due to lack of WHOOP straps at this stage). Out of the 134 that were randomized, 108 were enrolled. The primary reasons for attrition at this stage were due to pandemic-related reasons or loss of contact with the participants.
From the 108 subjects enrolled, 24 were randomized into the Mindfulness Meditation control condition and 84 were randomized to the treatment conditions (30 Cyclic Sighing, 21 Box Breathing, 33 Cyclic Hyperventilation with Retention). The initial randomization consisted of a permuted block randomization design with a block size of eight.
Both prior to and after the 28-day intervention, participants completed two brief questionnaires to assess the impact of the intervention on the daytime sequelae of sleep and anxiety: PROMIS Sleep Related Impairment - Short Form 8a, and the State-Trait Anxiety Questionnaire. Participants also completed a debriefing questionnaire at the end of the study. During the 28-day intervention period, participants did their assigned 5-minute exercise and completed two questionnaires before and after, the State Anxiety Inventory and the Positive and Negative Affect Schedule (PANAS). Participants received invitations to instructional videos (pre-recorded by Andrew D. Huberman) on the breathing exercises 3-5 days prior to the start of the study as well as daily text messages that reminded them to complete their exercises and pre-and-post-practice assessments. They were asked to complete the exercises only once a day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized prospective
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Meditation | Active comparator | Behavioral: Mindfulness Meditation5 minutes a day of mindfulness meditation practice for 28 days (passive attention to breath) delivered remotely through a video link. |
| Cyclic Sighing Breathing | Experimental | Behavioral: Cyclic Sighing Breathing5 minutes a day of active breathwork practice for 28 days delivered remotely through a video link. The protocol consists of slow inhales until lungs felt full then one more inhale to maximally fill the lungs, followed up a slow exhale. Repeat this cycle for 5 minutes. |
| Box Breathing | Experimental | Behavioral: Box Breathing5 minutes a day of active breathwork practice for 28 days delivered remotely through a video link. The protocol consists of equal duration of inhale, hold, exhale, hold cycles. The duration of the cycle is determined by the participant's comfort level with holding. (e.g. 4 sec inhale, 4 sec hold, 4 sec exhale, 4 sec hold). Repeat this cycle for 5 minutes. |
| Cyclic Hyperventilation with Retention | Experimental | Behavioral: Cyclic Hyperventilation with Retention5 minutes a day of active breathwork practice for 28 days delivered remotely through a video link. The protocol consists of 30 breaths (inhale deeply through the nose and exhale passively through the mouth) and after those 30 breaths, to exhale all their air via their mouth and to calmly wait with lungs empty for 15 seconds. Repeat this cycle for 5 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18
- Not pregnant
- Able to follow basic instruction for prescreen and scheduling
- Compliant with investigator instructions during the consent process and participation in the study
Key exclusion criteria (13 listed)
- Age <18
- Pregnant
- Non-English speaking
- Anyone with personality disorders or psychosis such as schizoaffective disorder
- Demonstrates evidence of severe psychiatric disorder in prescreen or email contact (as judged by Dr. Spiegel)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness MeditationParticipants are informed they should sit down in a chair or, if they preferred, to lie down, and then to set a timer for 5 minutes. Then they are told to close their eyes and to start breathing while focusing their mental attention on their forehead region between their two eyes. They are told that if their focus drifted from that location to re-recenter their attention by focusing back first on their breath and then on the forehead region between their eyes. They are told that as thoughts arise, to recognize that as normal, refocus their attention back to their forehead region and to continue the practice until time has elapsed. | Behavioural | Mindfulness Meditation |
| Cyclic Sighing BreathingParticipants are informed they should sit down in a chair or, if they prefer, to lie down, and to set a timer for 5 minutes. Then they are told to inhale slowly, and that once their lungs are expanded, to inhale again once more to maximally fill their lungs -- even if the second inhale was shorter in duration and smaller in volume than the first, and then to slowly and fully exhale all their breath. They are told to repeat this pattern of breathing for 5 minutes. They are also informed that ideally, both inhales would be performed via their nose and the exhale would be performed via their mouth, but that if they preferred, they are welcome to do the breathing entirely through their nose. They are also informed that it is normal for the second inhale to be briefer than the first. | Behavioural | Cyclic Sighing Breathing |
| Box BreathingParticipants are informed they should sit down in a chair or lie down, and to get a timer. Then they are told to take the "CO2 tolerance test" as follows: Take 4 breaths through the nose. Then take a maximally deep breath and once your lungs are full, exhale as slowly as possible through your nose or mouth. Time how long it takes to empty your lungs; this will be your C02 discard duration. Use your discard duration to determine how long your inhales, exhales, and breath holds should be (CO2 discard time) by using this table: <20 sec = 3 - 4 sec, 25 - 45 sec = 5 - 6 sec, 50 - 75+ sec = 8 -10 sec. They are then told to inhale, hold, exhale, hold (for the duration determined by the C02 discard table) and to repeat this pattern for the entire 5 minutes. If at any point they had to strain to reach these times, they should simply reduce the duration of inhales, exhales, and breath holds. We ask participants to perform all breathing through their nose, if possible. | Behavioural | Box Breathing |
| Cyclic Hyperventilation with RetentionParticipants are informed they should sit down in a chair or, if they prefer, to lie down, and to set a timer for 5 min. Then they are told to inhale deeply (ideally through their nose but if that is not possible, to inhale through their mouth) and then exhale by passively letting the air "fall out from the mouth". We inform them that for sake of this protocol, that pattern of a deep inhale through the nose and passively letting the air "fall out from the mouth" = 1 breath. Then they are instructed to perform 30 breaths (in and out) in this manner, and after those 30 breaths, to exhale all their air via their mouth and to calmly wait with lungs empty for 15 seconds. | Behavioural | Cyclic Hyperventilation with Retention |
Primary outcome
State Anxiety
Time frame: Daily from Day 0 to 29
STAI State Trait Anxiety
Trait Anxiety
Time frame: Day 0 and Day 29 (Baseline and Endpoint)
STAI State Trait Anxiety
Positive Affect
Time frame: Daily from Day 1 to 28
PANAS Positive Affect
Negative Affect
Time frame: Daily from Day 1 to 28
PANAS Negative Affect
Daytime Sleep Related Disturbance
Time frame: Day 0 and Day 29 (Baseline and Endpoint)
PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Sleep Related Impairment Short Form 8a
Resting Heart Rate
Time frame: Daily from Day 1 to 28
Daily obtained from WHOOP wrist band
Heart Rate Variability
Time frame: Daily from Day 1 to 28
Daily obtained from WHOOP wrist band
Respiratory Rate
Time frame: Daily from Day 1 to 28
Daily obtained from WHOOP wrist band
Sleep Duration
Time frame: Daily from Day 1 to 28
Daily obtained from WHOOP wrist band
Change in number of hours of sleep
Time frame: Daily from Day 1 to 28
Daily obtained from WHOOP wrist band as Hours of Sleep. Changes in the hours of sleep will be assessed with more hours indicating better sleep.
Change in the ratio of number of hours of sleep to hours in bed
Time frame: Daily from Day 1 to 28
Obtained daily from WHOOP wrist band as sleep efficiency. Changes in the Whoop Sleep Efficiency score will be assessed with higher score (ratio) indicating higher sleep efficiency.
1 secondary outcome
Adherence to Protocol
Time frame: Daily from Day 1 to 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Spiegel, M.D. principal investigator
Professor of Psychiatry, Stanford University
Andrew Huberman, Ph.D. principal investigator
Stanford University
Manuela Kogon, M.D. study director
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation, Cyclic Sighing Breathing and Box Breathing in people with Stress, Physiological and Stress, Emotional, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety (time frame: Daily from Day 0 to 29). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.